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United States · US · US:0310-6205_10d25358-e717-4294-9ec1-c73b8f45009d
FARXIGA
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11031062053030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)
- ndc11031062059090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90)
- ndc1103106205951 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
887K2391VH
DAPAGLIFLOZIN PROPANEDIOL
RxCUI 1486966
Orange Book
N202293
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "887K2391VH",
"rxcui": "1486966",
"inchikey": "GOADIQFWSVMMRJ-UPGAGZFNSA-N",
"display_name": "DAPAGLIFLOZIN PROPANEDIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"72ad22ae-efe6-4cd6-a302-98aaee423d69": {
"match": "brand_token",
"title": "FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "45",
"published_date": "2026-04-30"
}
},
"productid": "0310-6205_10d25358-e717-4294-9ec1-c73b8f45009d",
"productndc": "0310-6205",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202293",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jan 8, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jan 8, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN PROPANEDIOL",
"proprietary_name": "FARXIGA",
"active_ingred_unit": "mg/1",
"application_number": "NDA202293",
"marketing_category": "NDA",
"nonproprietary_name": "DAPAGLIFLOZIN",
"start_marketing_date": "20080114",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BK.
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